The web-based Corrective Action and Preventive Action management software application - ensurCAPA - grants you commanding flexibility when you find a nonconformance, accidents, incidents, supplier issues, and customer complaints with your products or production processes. The ability to collect, correlate, investigate, and make informed improvements can be automatically executed with ensurCAPA. Now you control streamlined quality and control throughout your manufacturing process.
The ensurCAPA software can be scaled-up as your company and product line grows due to your success. With global access throughout your corporation, you are kept up-to-date on the latest information. The ensurCAPA software provides you a configurable, comprehensive anytime, anywhere Corrective Action Preventive Action tool. The web forms help guide you in fully identify, define, investigate and correct any nonconformance you have found. The configurable lifecycle allows you to monitor your solution from draft through effective verification of your corrective action/preventative action.
You will meet your compliance objectives for ISO, cGxP, OSHA, SQF, FDA 21 CFR Parts 11, 211, and 820.
Authoritative Features of ensur's CAPA software:
- Link incidents and CAPAs to work instructions, procedures, training events, and specifications stored within the ensur repository.
- Collaborate on the definition and resolution of Corrective and Preventive Actions.
- Allow users of ensur to enter incidents and generate Corrective Action Preventive Action requests by site, supplier, customer, product, and more using web forms.
- Associate multiple incidents, complaints, and investigations to CAPAs.
- Collaborate on Root Cause Analysis and developing appropriate Action Plans in Corrective Action or Preventative Action Requests.
- Assign specifc employees, departments, or teams Action Items.
- Upload and attach any file type to incidents and CAPAs.
- Automated workflow that can be changed when needed.
- Automated email notifications to all parties involved in an incident and/or CAPA.
- Comprehensive detailed audit trails on user actions, names, dates, and times of when CAPAs or incidents have been created, reviewed, analyzed, implemented, modified, verified, deferred, and closed.
- Generate reports and export data to track trends, measure improvements, and analyze your Corrective Action and Preventative Action process.
- Upload and use your current CAPA forms.
- 360o Audit Trail
- Out-of-the-box web-forms to begin immediately or design your own at no additional cost.
- Meet FDA , cGxP, ISO, SQF, and other compliance standards.
ensur is more than a corrective action/preventive action software solution. Based upon your configuration ensur will give you access to documents, training, change control, complaints and CAPAs launched from one web-based software application.